CraNIRS Clinical Study

NCT04086056 | Completed

• 2 other identifiers: 69HCL19_05682019-A02390-57
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems. In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses. In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull. Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.

Conditions

Craniosynostoses

Outcome Measures

Primary Outcomes (3)

• Regional cerebral oxygen saturation measure

  Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

  Day 0 before anesthesia

• Regional cerebral oxygen saturation measure

  Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

  Day 0 during surgery

• Regional cerebral oxygen saturation measure

  Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

  Day 0 after extubation

Study Arms (1)

Children with craniosynostosis

Children with craniosynostosis who will be operated in prone position.

Other: NIRS monitoring

Interventions

NIRS monitoring OTHER

Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.

Children with craniosynostosis

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with craniosynostosis.

You may qualify if:

• Boys and girls.
• Aged 3 to 18 months old.
• Subjects with a craniosynostosis diagnosis confirmed by imaging.
• Craniosynostosis requiring a corrective surgery in ventral position.
• Parents/ legal guardian must provide non opposition prior to participation in the study.

You may not qualify if:

• \- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon service neurochirurgie pédiatrique

Bron, 69500, France

Location

MeSH Terms

Conditions

Craniosynostoses

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Federico DI ROCCO

  Hospices Civils de Lyon service neurochirurgie pédiatrique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 11, 2019
• Study Start: January 20, 2020
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)